Replies to post #3375 on NorthWest Biotherapeutics Inc (NWBO)

[TheRedBaron888]

Some more thoughts.......I wasn't expecting anything on Direct. My concern, since late last year, has been far more on Germany. The Direct trial has already started. At two prestigious centres. We've had to make heavy investments through the whole of last year to see through the stringent early phase of this first-in-human trial. By now, I would expect most of the investment required to have already been made. And hence, I am fully confident of that investment's "operating leverage" to start kicking-in, starting from March-April this year. And Linda's emphasis today on efficacy, where many companies would have opted for the safer "drug-is-well-tolerated" approach, was encouraging.

It is Germany that has been bothering me. And that concern, to an extent, was addressed today. Though only real progress in terms of centres opening will help me rest easy on that front. The number of persons being trained gives me the hope that not just the start, but a broad start, in terms of the number of centres opening, is likely in the next 4-6 weeks.

[flipper44]

Good Points Red,


At the risk of repeating myself, I want to reiterate what impressed me the most.

I've been waiting for someone to give me compassionate use statistics,

Last evening, we finally received them.


Not including the phase 3 trial on DCVAX-L, over 200 patients received over 1000 treatments with DCVAX-L over the past 10 years.


* The cancers included (but were not limited to) Brain, Esoghageal and Merkel cell carcinoma.
* More than 80% of those 200 patients responded to DCVAX-L.
* Progression Free Survival (PFS) was, on average, extended at least one-and-a-half years beyond standard of care.
* Overall Survival (OS) was, on average, extended at least one-and-a-half years beyond standard of care.
* Only one patient had a serious adverse event possibly related to DCVAX-L out of 200 very sick cancer patients over 10 years.


(Prior to last night, we received a much smaller sampling from approximately 37 total patients in 2-3 phase 1/2 trials. In other words, last night's presentation just added over 160 patients worth of information.)